Phase 1 Eating Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older
• People who meet the clinical criteria for Bulimia Nervosa, as measured by a specific assessment tool called the EDA-5
• People who are able to give written informed consent to participate
• People who are able to swallow pills
• People who agree to have their study visits recorded, including therapy sessions and experimental sessions
• People who can provide the name of a relative, spouse, close friend, or other support person who can be contacted by the research team if needed
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures
• People who are able to become pregnant must have a negative pregnancy test at the start of the study and before each experimental session, and must agree to use an approved form of contraception until 10 days after the last experimental session (confirm with trial site for full list of accepted contraceptive methods)
• People who agree to certain lifestyle changes required during the study (confirm with trial site for details)
• People who live within approximately a 2-hour drive of the study site
• People who have an identified regular doctor (GP or primary care physician) and agree to allow the research team to contact that doctor if necessary
• People whose Bulimia Nervosa has continued despite having already completed at least one eating disorder-specific treatment program (such as inpatient, residential, partial hospitalisation, or intensive outpatient treatment), confirmed by medical records or a treating doctor
• People who are considered medically stable based on heart tracing (ECG), blood pressure, blood and urine tests, and medical history review

Who may not be able to join:

• People whose liver enzyme levels (ALT or AST) or bilirubin levels are significantly above the normal range on blood tests
• People whose kidney function, as measured by a blood test called eGFR, falls below a certain level
• People with unstable liver or bile duct disease, such as those with cirrhosis, jaundice, or related complications (some stable liver conditions may still be acceptable — confirm with trial site)
• People who make themselves vomit more than 14 times per week
• People with active, symptomatic Hepatitis C
• People with a moderate or severe alcohol or cannabis use disorder, or those in early recovery from one in the three months before enrolling
• People with Type 1 Diabetes or poorly controlled Type 2 Diabetes
• People with untreated underactive thyroid (hypothyroidism)
• People who, in the opinion of the research team, appear unlikely to have stable housing or adequate social support
• People who have used ecstasy (or substances represented as MDMA) more than 10 times in the past 10 years, or at least once in the 6 months before the first experimental session
• People who have previously taken part in an MDMA clinical trial run by MAPS
• People with any current condition that, in the research team's judgment, could interfere with safe participation
• People who have a known allergy or sensitivity to any ingredient in the study drug
• People who have received electroconvulsive therapy (ECT) within 12 weeks before enrolling
• People with a current or past primary psychotic disorder, Bipolar Disorder Type 1, or dissociative identity disorder, as confirmed through clinical assessment
• People with current major depression that includes psychotic features
• People with a current moderate or severe alcohol or cannabis use disorder within the 12 months before enrolling
• People with any active substance use disorder (other than cannabis) in the 12 months before enrolling
• People assessed as currently having serious suicide risk based on clinical interview and standardised assessment tools; certain patterns of suicidal thoughts or behaviour in the past 6 months may also be reason for exclusion (confirm with trial site for full details)
• People considered to present a serious risk of harm to others
• People who require ongoing psychiatric medication that is not compatible with the study (confirm with trial site for exceptions)
• People with a medical history that makes it unsafe to receive a drug that raises blood pressure and heart rate — including, but not limited to, prior heart attack, stroke, or aneurysm
• People with a 10-year cardiovascular risk score of 7.5% or higher on a standard risk calculator
• People whose physical activity capacity falls below a certain level on a standard fitness assessment tool (confirm with trial site)
• People with uncontrolled high blood pressure at Stage 2 level (140/90 mmHg or above, measured on three separate occasions)
• People with a history of serious heart rhythm problems (ventricular arrhythmia), other than occasional minor irregularities in the absence of heart disease
• People with Wolff-Parkinson-White syndrome or a similar heart conduction abnormality that has not been successfully treated
• People with a history of certain other heart rhythm disorders in the past 12 months (some older, successfully treated cases may be considered — confirm with trial site)
• People whose heart tracing (ECG) shows a prolonged QT interval above a certain threshold
• People with additional risk factors for a specific serious heart rhythm complication called Torsade de pointes (such as heart failure, low potassium, or a family history of Long QT Syndrome)
• People who need to take medications during experimental sessions that are known to prolong the QT interval (confirm with trial site)
• People with a history of abnormally low sodium levels or dangerous overheating (hyponatremia or hyperthermia)
• People who weigh less than 48 kilograms
• People who are pregnant, breastfeeding, or able to become pregnant and not using an effective form of contraception
• People with a significant fear of blood or needles that would prevent the necessary blood tests from being completed
• People with any allergy or sensitivity to the study drug or its components that, in the research team's opinion, makes participation unsafe
• People who are not comfortable participating in therapy and completing assessments in English
• People whose blood test (full blood count) shows a blood disorder or infection that would be a reason not to receive the study drug
• People whose thyroid blood test (TSH) indicates an overactive thyroid, which could interfere with the body's ability to regulate temperature during the study
• People whose urine test results indicate abnormal electrolyte levels or kidney problems

Important: Always verify eligibility with the trial site directly before applying.